Search Results
Found 2 results
510(k) Data Aggregation
K Number
K981047Device Name
FRESH AIR
Manufacturer
COLORADO MEDTECH, INC.
Date Cleared
1999-09-16
(545 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
COLORADO MEDTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Oxygen concentration by means of molecular sieve technology, yielding supplemental product oxygen in conformance with official USP designation "Oxygen 93 Percent", and supplemental delivery for oxygen therapy.
Note: The intended use of this system is as a secondary oxygen source. The primary oxygen source for the facility is normally provided by liquid oxygen and distributed in a gaseous state via (typically) 'H' or 'K' supply cylinders in a conventional configuration. (reference: NFPA 99C,1996, fig. 4-3.1.1.6)
Device Description
FreshAir System
Ask a Question
K Number
K955890Device Name
FIRST MEDIC PULSE OXIMETRY MODULE
Manufacturer
COLORADO MEDTECH, INC.
Date Cleared
1997-07-28
(577 days)
Product Code
MKJ
Regulation Number
870.5310Why did this record match?
Applicant Name (Manufacturer) :
COLORADO MEDTECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
Ask a Question
Page 1 of 1